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My co-authors and I thank Sani et al. [1] for their interest in our paper [2]. We agree that there is a clear difference between clinical importance and statistical significance.
For the studies that used the SF-36 to assess health-related quality of life (HRQoL), the absolute difference between osteoporotic patients with and without vertebral fractures was 7.8. The minimal clinically important difference for physical function assessed by the SF-36 has been identified as 5.3 in the setting of other musculoskeletal conditions (osteoarthritis) [3].
In addition, although the minimal clinically important difference has not been established for the QUALEFFO or other measures of HRQoL, the standardized mean difference (SMD) for physical function for all studies combined was classed as a moderate difference for physical HRQoL, using standard recommendations [4].
Both these methods confirm that, based on our meta-analysis, the difference in physical HRQoL between those with and without vertebral fractures appears to be clinically meaningful. Therefore, we stand by our conclusion that osteoporotic patients with vertebral fractures have moderately reduced physical health status compared to osteoporotic patients without vertebral fracture.
References
Sani M, Ayubi E, Khazaei S, Mansori K (2016) Health-related quality of life in older people with osteoporotic vertebral fractures: clinically important vs. statistically significant. Osteoporos Int. doi:10.1007/s00198-016-3725-1
Al-Sari U, Tobias J, Clark E (2016) Health-related quality of life in older people with osteoporotic vertebral fractures: a systematic review and meta-analysis. Osteoporos Int. doi:10.1007/s00198-016-3648-x
Angst F, Aeschlimann A, Stucki G (2001) Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 qualitt of life measurement instruments in patients with osteoarthritis of the lower extremeties. Arthritis Care Res 45(4):384–391
Cohen J (1988) Statistical power analysis for the behavioral sciences, 2nd edn. Erlbaum, Hillsdale, NJ
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Clark, E. Health-related quality of life in older people with osteoporotic vertebral fractures: response to comments by Sani et al.. Osteoporos Int 27, 3663 (2016). https://doi.org/10.1007/s00198-016-3726-0
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DOI: https://doi.org/10.1007/s00198-016-3726-0